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Dynamic Risk-adapted EBV-DNA and MRI-guided De-concurrent Chemotherapy in Nasopharyngeal Carcinoma

9 augusti 2026 uppdaterad av: Chaosu Hu, Fudan University

Dynamic Risk-adapted EBV-DNA and MRI-guided De-concurrent Chemotherapy in Nasopharyngeal Carcinoma: A Prospective Single-center Phase II Study

This study aims to explore the efficacy and safety of risk-adapted adjuvant therapy based on dynamic EBV-DNA changes and MRI in nasopharyngeal carcinoma patients.

Studieöversikt

Detaljerad beskrivning

This study aims to evaluate whether the 2-year failure-free survival of NPC patients treated with GP induction chemotherapy, IMRT and risk-adapted adjuvant therapy based on dynamic EBV-DNA changes and MRI results at the end of radiotherapy, is superior to that of a historical control cohort receiving standard treatment.

Studietyp

Interventionell

Inskrivning (Beräknad)

148

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200032
        • Rekrytering
        • Fudan Universtiy Shanghai Cancer Center
        • Kontakt:
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

  • Age: 18 - 65 years old
  • Pathologically confirmed nasopharyngeal carcinoma, WHO type II or III non-keratinizing squamous cell carcinoma.
  • AJCC/UICC 9th edition stage II - III; excluding patients with T3N0M0 (only posterior pharyngeal lymph node metastasis) and T3N1M0.
  • Baseline plasma EBV-DNA > 0, and able to complete dynamic monitoring according to the protocol.
  • ECOG 0 - 1.
  • Main organ functions meet the requirements: neutrophils ≥ 2.0×10^9/L, platelets ≥ 100×10^9/L, hemoglobin ≥ 90 g/L; ALT/AST ≤ 1.5×ULN, total bilirubin ≤ 1.5×ULN; creatinine clearance rate ≥ 60 mL/min.
  • Signed informed consent form, willing to complete the study according to the protocol.

Exclusion Criteria:

  • Clinical or imaging examinations have confirmed distant metastasis.
  • Before the diagnosis of nasopharyngeal carcinoma, the patient had received chemotherapy, targeted therapy, or immunotherapy, and had a history of radiotherapy or surgery for head and neck tumors (except for diagnostic biopsies).
  • Has an active autoimmune disease, but the following conditions are excluded: type 1 diabetes, hypothyroidism receiving replacement therapy, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or alopecia).
  • Active hepatitis B with poor control of HBV DNA, active hepatitis C, HIV infection or uncontrolled infection.
  • Within 4 weeks before signing the informed consent form, the patient had used systemic glucocorticoids (equivalent to prednisone dose > 10mg/day) or other immunosuppressive treatments; if the patient's systemic glucocorticoid dose is equivalent to prednisone ≤ 10mg/day or only uses inhaled or topical glucocorticoids, participation is allowed.
  • Has a history of active tuberculosis (Mycobacterium tuberculosis infection) in the past year; if active tuberculosis has been fully treated and has been over one year ago, participation is allowed.
  • Has a history of interstitial lung disease.
  • Has received live vaccines within 4 weeks before signing the informed consent form, or is about to receive live vaccines in the near future.
  • Pregnant or lactating women, or reproductive-aged subjects who do not agree to take effective contraceptive measures.
  • Has a history of other malignant tumors within the past 5 years, but the following situations are excluded: cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, papillary thyroid carcinoma, etc.
  • Cannot take oral medications or have a known severe allergy to capecitabine, tislelizumab, or cisplatin/gemcitabine.
  • Has any other conditions, including symptomatic heart failure, unstable angina pectoris, myocardial infarction, active infections requiring systemic treatment, mental illness or family/social factors, which the investigator believes may affect the patient's ability to sign the informed consent form, cooperate and participate in the study, or interfere with the interpretation of the study results.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: Low-risk group

Patient treated with induction chemotherapy(Gemcitabine 1000 mg/m², administered intravenously on days 1 and 8; Cisplatin 80 mg/m², administered intravenously on day 1 or in 3 divided doses; 1 cycle every 21 days, for a total of 2 cycles), followed by IMRT. Then received risk-adapted adjuvant therapy based on dynamic EBV-DNA changes and MRI results at the end of radiotherapy.

Clinical follow-up and surveillance only for low-risk group

Clinical follow-up and surveillance only.
Experimentell: Medium-risk group
Capecitabine for medium-risk group after IMRT
Capecitabine for medium-risk group Capecitabine: 1000 mg/m² orally twice daily on days 1-14,every 3 weeks. Treatment duration: 8 cycles

Tislelizumab and Capecitabine for high-risk group. Tislelizumab: 200 mg ivgtt on day 1, every 3 weeks and capecitabine: 1000 mg/m² orally twice daily on days 1-14,every 3 weeks.

Treatment duration: 8 cycles(Maintenance of tislelizumab could be used in some high-risk patients after 8 cycles)

Experimentell: High-risk group
Tislelizumab and Capecitabine for high-risk group after IMRT
Capecitabine for medium-risk group Capecitabine: 1000 mg/m² orally twice daily on days 1-14,every 3 weeks. Treatment duration: 8 cycles

Tislelizumab and Capecitabine for high-risk group. Tislelizumab: 200 mg ivgtt on day 1, every 3 weeks and capecitabine: 1000 mg/m² orally twice daily on days 1-14,every 3 weeks.

Treatment duration: 8 cycles(Maintenance of tislelizumab could be used in some high-risk patients after 8 cycles)

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
2-year Failure Free Survival, 2-y FFS
Tidsram: 2 years
calculated from the date of diagnosis of NPC to the date of tumor recurrence, progression, distant metastasis or death due to any cause,whichever comes earlier.
2 years

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overal Survival,OS
Tidsram: 2 years
calculated from the date of diagnosis of NPC to the date of death from any cause
2 years
Locoregionally Failure Free Survival,LRFFS
Tidsram: 2 years
calculated from the date of diagnosis of NPC to the date of locoregional failure or date of death from any cause, whichever comes earlier.
2 years
Distant failure free survival, DFFS
Tidsram: 2 years
calculated from the date of diagnosis of NPC to the date of distant metastasis or date of death from any cause, whichever comes earlier.
2 years
Adverse effects (AE)
Tidsram: during and after treatment (up to 2 years)
during and after treatment (up to 2 years)
Objective Response Rate
Tidsram: at the end of, 3 months and 6 months after IMRT
at the end of, 3 months and 6 months after IMRT

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Xiayun He, Fudan University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 augusti 2026

Primärt slutförande (Beräknad)

1 juli 2028

Avslutad studie (Beräknad)

1 juli 2031

Studieregistreringsdatum

Först inskickad

5 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

9 augusti 2026

Första postat (Faktisk)

13 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

13 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

9 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

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NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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